Whether you have just come up with the most scrumptious recipe for low calorie chocolate chip cookies or signed a distributorship agreement for the next diet pill craze, there are a few legal steps to be taken before your product can hit the market. Depending on the nature of the product, it may require registration pursuant to the Food and Drugs Act and its Regulations (the “Act” and “Regulations”), which are administered by the Ministry of Health (the “Ministry”).
One of the primary goals of the Ministry is to ensure that products, namely foods, drugs, cosmetics and medical devices meet certain minimum health and safety standards. Further, if a manufacturer claims that a product has certain health benefits, including claims that the product is good for the treatment of certain diseases or other health conditions, the Ministry will conduct certain checks and tests to determine that the product actually provides those benefits.
Let’s say your product is a food or a cosmetic. The Act defines a “food” as including “any article used for food or drink by man, chewing gum and any ingredient that may be mixed with food or drink for any purpose”. Cosmetics on the other hand refers to “any substance or mixture of substances…represented for use in cleansing, improving or altering the complexion, skin, lips, hair, fingernails or toenails, teeth, and includes deodorants and perfumes.”
The Act and Regulations generally provide that food and cosmetics are to be manufactured, prepared, preserved, packaged and stored under sanitary conditions; they shall not contain any filthy or decomposed substance or foreign matter; must not be adulterated or stale; and must be fit for human consumption. Such products must be correctly labeled in accordance with the Act and Regulations and any applicable standard under the Standards Act. For example, the main panel of a food label must generally state the brand name or trade name; the common name of the food; and a statement of the weight, volume, number or measure of contents. The remainder of label would include a declaration of added colour, if present; the name and address of the manufacturer, packer, importer, vendor or of any person who assumes the responsibilities of the manufacturer, packer, importer or vendor.
Using the low calorie cookie recipe as an example, in order to sell these prepackaged cookies to the public, you would have to ensure that that the description used, complies with the Regulations. A food cannot be described as being “sugar free” unless it contains no more than 0.25 percent glycogenic carbohydrates. A food also cannot be described as “low-caloried” unless it contains contains a per average serving calorie amount less than that specified in the Regulations.
Under the Act, a drug refers to among other things, a substance sold or represented for use in the diagnosis, treatment or prevention of a disease or disorder or for restoring or correcting an organic function. All drugs (including over the counter drugs) are to be registered with the Ministry and a permit obtained from the Ministry for the sale in and importation of the product into Jamaica. After the Ministry determines that a product should be treated as a drug, it will be further classified by the Pharmacy Council of Jamaica. This classification will establish whether the product can be made available for general free sale, sale in pharmacies only or by prescription.
Typically, when we think of a drug, we think of a tablet we may take to get rid of a headache or medicine obtained from a pharmacist to help get over the flu. However, based on the definition in the Act an item one would ordinarily think of as a food or cosmetic may be classified as a drug based on the health claims/benefits proclaimed by the manufacturer. For instance, cosmetics for cleansing, hygiene and enhancement of beauty by means which do not interfere with usual body functions would not need to be registered. However, if the manufacturer claims the product is able to prevent, cure or treat any disease, disorder or abnormal physical condition, it could ultimately be registered as a drug. Nutritional mixes, bars and other food supplements are also often classified as drugs.
Ultimately, if you are unsure as to whether a product falls into any of the categories discussed, we recommend that the label and formula information be submitted to the Ministry in order to obtain their guidance. You may end up having to shelf that product for some time while you await the Ministry’s feedback. Sometimes, that’s just how the cookie crumbles.
Simone Bowie is an Associate at Myers Fletcher & Gordon and is a member of the firm’s Commercial Department. She may be contacted at simone.bowie@mfg.com.jm or you can visit our new website at www.myersfletcher.com.
